Trial Outcomes & Findings for ABT-335 (Choline Fenofibrate) Reverse Cholesterol Transport (RCT) Study (NCT NCT00673881)

Results Overview

Mean change in calculated LDL, baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,average Day 95)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

25 participants

Primary outcome timeframe

baseline to 12 weeks

Results posted on

2011-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	ABT 335 choline fenofibrate, 135 mg/day,orally, 12 weeks
Overall Study STARTED	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ABT 335 choline fenofibrate, 135 mg/day,orally, 12 weeks
Overall Study Withdrawal by Subject	1

Baseline Characteristics

ABT-335 (Choline Fenofibrate) Reverse Cholesterol Transport (RCT) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABT 335 n=25 Participants choline fenofibrate, 135 mg/day,orally, 12 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants
Total cholesterol (TC)	221 mg/dL STANDARD_DEVIATION 45 • n=5 Participants
Triglycerides (TG)	241 mg/dL STANDARD_DEVIATION 122 • n=5 Participants
High Density Lipoprotein Cholesterol (HDL)	34 mg/dL STANDARD_DEVIATION 8.2 • n=5 Participants
Low density lipoprotein cholesterol (LDL)	144 mg/dL STANDARD_DEVIATION 40 • n=5 Participants

PRIMARY outcome

Timeframe: baseline to 12 weeks

Mean change in calculated LDL, baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,average Day 95)

Outcome measures

Outcome measures
Measure	ABT 335 n=23 Participants choline fenofibrate, 135 mg/day,orally, 12 weeks
Mean Change in Calculated Low Density Lipoprotein Cholesterol	-22.7 mg/dL Standard Deviation 34.2

PRIMARY outcome

Timeframe: baseline to 12 weeks

Population: per protocol

Change in plasma triglyceride, baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,Day 95)

Outcome measures

Outcome measures
Measure	ABT 335 n=23 Participants choline fenofibrate, 135 mg/day,orally, 12 weeks
Mean Change in Plasma Triglycerides	-138.0 mg/dL Standard Deviation 150.5

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Mean change in plasma high density plasma lipoprotein cholesterol (HDL-C)baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,Day 95)

Outcome measures

Outcome measures
Measure	ABT 335 n=23 Participants choline fenofibrate, 135 mg/day,orally, 12 weeks
Mean Change in High Density Lipoprotein Cholesterol	-1.6 mg/dL Standard Deviation 6.0

PRIMARY outcome

Timeframe: 12 weeks

Mean Change in total cholesterol from baseline to End-of-treatment (Day 95)

Outcome measures

Outcome measures
Measure	ABT 335 n=23 Participants choline fenofibrate, 135 mg/day,orally, 12 weeks
Total Cholesterol	-54.0 mg/dL Standard Deviation 34.4

SECONDARY outcome

Timeframe: 12 weeks

Change in efflux rate from baseline to end-of-treatment. The efflux rate of cholesterol from peripheral tissues into the plasma was measured as mg/kg/hr. An IV infusion of \[13C2\] cholesterol mixed in 10% Intralipid® or Liposyn® and 10 % ethanol was given piggy-backed into normal saline over 24 hours. This was used to determine rate of appearance (Ra) cholesterol, measured by dilution of infused \[13C2\] cholesterol during the plateau phase of plasma enrichment (approximately the last 4 hours of the infusion), as well as to provide the plasma cholesterol traced into biliary sterols.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Change in FCR from baseline to end-of-treatment (12 weeks)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Plasma DNC was measured three times from blood draws on the 3 visits in the 10 day period following the isotope infusion at baseline and again at end-of-treatment at 12 weeks, and expressed in percent. Change from baseline to end-of-treatment expressed as percent.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to 12 weeks

The excretion rate of fecal neutral and acidic sterols was measured as mg/day, for each individual three times during the 10 day period following the isotope infusions at baseline and end-of-treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Change in bile acid excretion from baseline to end-of-treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Change in neutral sterol endogenous excretion from baseline to end-of-treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Change in endogenous bile acid excretion from baseline to end-of-treatment

Outcome measures

Outcome data not reported

Adverse Events

ABT 335

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ABT 335 n=25 participants at risk choline fenofibrate, 135 mg/day,orally, 12 weeks
Gastrointestinal disorders diarrhoea	12.0% 3/25 • 12 weeks All adverse events occurring during the study are reported - the study included a treatment period, with pre-study baseline and post-study end-of-treatment procedures.
Gastrointestinal disorders Dyspepsia	8.0% 2/25 • 12 weeks All adverse events occurring during the study are reported - the study included a treatment period, with pre-study baseline and post-study end-of-treatment procedures.
Injury, poisoning and procedural complications Contusion	8.0% 2/25 • 12 weeks All adverse events occurring during the study are reported - the study included a treatment period, with pre-study baseline and post-study end-of-treatment procedures.
Musculoskeletal and connective tissue disorders back pain	16.0% 4/25 • 12 weeks All adverse events occurring during the study are reported - the study included a treatment period, with pre-study baseline and post-study end-of-treatment procedures.
Musculoskeletal and connective tissue disorders Muscle spasms	12.0% 3/25 • 12 weeks All adverse events occurring during the study are reported - the study included a treatment period, with pre-study baseline and post-study end-of-treatment procedures.
Nervous system disorders Headache	8.0% 2/25 • 12 weeks All adverse events occurring during the study are reported - the study included a treatment period, with pre-study baseline and post-study end-of-treatment procedures.
Respiratory, thoracic and mediastinal disorders rhinorrhea	12.0% 3/25 • 12 weeks All adverse events occurring during the study are reported - the study included a treatment period, with pre-study baseline and post-study end-of-treatment procedures.

Additional Information

Michael H. Davidson, MD FACC

Radiant Research

Phone: 312-494-2220

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place